The following data is part of a premarket notification filed by Beijing Choice Electronic Technology Co., Ltd. with the FDA for Wrist Pulse Oximeter.
Device ID | K172366 |
510k Number | K172366 |
Device Name: | Wrist Pulse Oximeter |
Classification | Oximeter |
Applicant | Beijing Choice Electronic Technology Co., Ltd. No.9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan Dist Beijing, CN 100041 |
Contact | Lei Chen |
Correspondent | Lei Chen Beijing Choice Electronic Technology Co., Ltd. No.9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan Dist Beijing, CN 100041 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-04 |
Decision Date | 2018-03-16 |
Summary: | summary |